Conflicts of Interest - IRB Members

POLICY

CPHS members and consultants may not participate in the review of any protocol in which they have a conflicting interest, except to provide information requested by the CPHS. 

Key Terms:

Significant financial interest - Significant financial interest in research is defined as the aggregate interests of the investigator and his/her immediate family (spouse and dependent children). It also refers to anything of monetary value that would reasonably appear to be affected by the outcome of the proposed research, regardless of whether that entity is sponsoring the research. The term significant financial interest is defined in the HOOP Policy 94 – Research Conflicts of Interest.

Any other financial interests if the CPHS Members have concerns that these interests would reasonably appear to be affected by the proposed research (e.g. significant financial interests of family members other than a spouse or dependent children)

Non-financial interests – Non-financial conflicting interest include personal or scientific interest in the research or direct involvement in design, conduct or reporting of the research.   

PROCEDURE

Identifying Conflicting Interests – IRB members and consultants must disclose any significant financial or non-financial interests related to the research being reviewed.

At the start of all CPHS meetings, the IRB chair will remind members and consultants in attendance at the meeting, to declare any conflicting interests with items on the agenda.

Managing Conflicting Interests - A member or consultant with a conflicting interest must excuse himself/herself from the meeting prior to any discussion, except to provide information requested by the CPHS. This absence does affect the number of persons necessary for a quorum, and the member will be noted in the minutes as not present for vote. Even when a member does not have conflicting interest as defined in this policy, they may refrain from discussion and vote to avoid any appearance of a conflicting interest. 

Members with conflicting interests will not be assigned as primary or secondary reviewers for review of the specific research protocol for which conflict exists for initial review, continuing review, expedited review, review of protocol amendments, review of SAE reports and review of non-compliance reports.

APPLICABLE REGULATIONS

  1. 45 CFR 46 Protection of Human Subjects
  2. 21 CFR 56 Institutional Review Board

REFERENCES TO OTHER POLICIES

  1. HOOP 94 Research Conflict of Interests
  2. 101-B03 – IRB Meetings

ATTACHMENTS

  1. None

If you find errors in this document, contact cphs@uth.tmc.edu

 

Document Number:

101-B04

Document Name:

Conflict of Interest – CPHS Members and Consultants

Approved by:

Executive Director, Research Compliance

Effective:

1 Aug 2008

Revision History:

1 Aug 2011, 1 Jun 2016, 21 Jan 2019, 1 Jun 2021

 




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